s0025 irinotecan in treating patients with refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer

Conditions: Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of irinotecan in treating patients who have refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer.

objectives: * determine the objective confirmed and unconfirmed complete and partial response rates of patients with platinum- and taxane-refractory ovarian epithelial, primary peritoneal, or fallopian tube cancer treated with irinotecan. * determine the progression-free and overall survival of patients treated with this drug. * evaluate the qualitative and quantitative toxic effects of this drug in these patients. outline: patients receive irinotecan iv over 90 minutes on days 1 and 8. courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed every 6 months for 3 years. projected accrual: a total of 20-40 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or pathologically confirmed ovarian epithelial, primary peritoneal, or fallopian tube cancer * no mixed mullerian and borderline ovarian tumors * surgically staged as stage iii or iv at initial diagnosis * must meet one of the following criteria for refractory/relapsed disease: * relapsed within 6 months after completing front-line concurrent or sequential platinum (either cisplatin or carboplatin) and taxane (paclitaxel or docetaxel) chemotherapy * had a best response of increasing disease during this front-line regimen * consolidation chemotherapy and reinduction therapy are counted as part of the front-line regimen * unidimensionally measurable disease * at least 2 cm by medical photograph (skin or oral lesion), palpation, plain x-ray, ct scan, mri, or other conventional technique (bone lesions not included) * at least 1 cm by spiral ct scan * measurable disease must remain outside of radiotherapy field * if the tumor is known to be kit (cd117) or pdgfr positive, patient must be offered swog-s0211 if available patient characteristics: age * not specified performance status * zubrod 0-2 life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified cardiovascular * no myocardial infarction within the past 6 months * no angina pectoris * no uncontrolled congestive heart failure * no uncontrolled cardiac arrhythmia other * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no other malignancy within the past 5 years except for the following: * adequately treated basal cell or squamous cell skin cancer * carcinoma in situ of the cervix * adequately treated stage i or ii cancer from which the patient is currently in complete remission prior concurrent therapy: biologic therapy * no more than 1 prior biological response modifier * at least 28 days since prior biological response modifier and recovered chemotherapy * see disease characteristics * no prior topotecan or other topoisomerase i inhibitor * one other additional prior chemotherapy regimen allowed * at least 28 days since prior chemotherapy (14 days for weekly chemotherapy) and recovered endocrine therapy * prior hormonal therapy allowed * no concurrent hormonal therapy radiotherapy * at least 28 days since prior radiotherapy and recovered * no prior radiotherapy to more than 25% of bone marrow * no concurrent palliative radiotherapy surgery * at least 14 days since prior major surgery and recovered other * at least 28 days since prior investigational drugs and recovered * no other concurrent antitumor therapy

Keywords: recurrent ovarian epithelial cancer fallopian tube cancer primary peritoneal cavity cancer stage iii ovarian epithelial cancer stage iv ovarian epithelial cancer